Advanced Pharma Recalls Early Baby TPN Due to Latex Labeling
Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) because the product may contain synthetic or natural latex, which is not currently labeled.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error regarding latex content, which fits the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) in all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall involves all lots of the product.
The recall was initiated due to a labeling issue. The product may contain synthetic latex and/or natural latex, but this information is not currently classified or labeled on the product. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should discontinue use of the affected product. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Parenteral Nutrition
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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